Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older (these blood conditions are very rare in children)
• People diagnosed with myelofibrosis (MF) according to recognised medical classification systems, who either: have had at least one previous treatment for MF, or had a poor response after at least 3 months on a JAK inhibitor medication (for the early phase of the trial); or fit into one of the expansion groups — either having had at least one prior MF treatment, or being newly diagnosed and treatment-naive with intermediate or higher risk disease (confirm which group applies with the trial site)
• People diagnosed with a type of blood cancer called CMML, where treatment with hydroxyurea or a class of drugs called hypomethylating agents has not worked well, or where the person could not tolerate those treatments
• People whose general physical functioning is rated at a level of 2 or below on a standard medical scale (meaning they are able to care for themselves but may not be able to do heavy physical work)
• People whose liver is functioning adequately, based on blood test results within acceptable ranges
• People whose kidneys are functioning at a sufficient level (a clearance rate above 30 mL/min, with no end-stage kidney disease)
• People who have previously used hydroxyurea for white blood cell control, or certain blood-stimulating growth factor medications, at any time before starting the trial
• People who have signed (or whose legal representative has signed) a document confirming they understand and agree to participate in the study — non-English speaking patients may also be included
• People who have had, or currently have, another cancer, where that cancer or its treatment is unlikely to interfere with the safety or results of this trial
• People with a history of heart disease who are assessed as Class 2B or better using a standard heart function classification system
• People who are able to use adequate contraception for the duration of the trial (specific approved methods are listed and must be discussed with the trial site)

Who may not be able to join:

• People currently receiving active treatment for another cancer (exceptions may apply for certain early-stage or low-risk cancers such as basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma in situ, early-stage breast cancer, or localised prostate cancer treated with hormone therapy — confirm with trial site); people with a history of other cancers generally need to have been free of that disease for at least 2 years
• People currently taking any other experimental (investigational) medication, or who have previously been treated with a type of drug called a CSF1-R inhibitor
• People with an active, uncontrolled infection (bacterial, fungal, parasitic, or viral) that is not yet under control with appropriate treatment
• People with signs of active or latent (hidden/dormant) tuberculosis
• People with a condition that affects how the body absorbs medication through the digestive system, such as having had part of the stomach surgically removed
• People with a history of acute or chronic pancreatitis (inflammation of the pancreas)
• People with currently active and symptomatic muscle inflammation (myositis)
• People with a platelet count below 50 x 10⁹/L before starting treatment (this applies only to certain combination treatment groups in the trial, unless the low count is directly caused by MF, CMML, or prior chemotherapy — confirm with trial site)
• People who are pregnant, as the study medications carry a risk of harm to an unborn baby; people who are breastfeeding would also need to stop breastfeeding to participate
• People who are unwilling or unable to follow the required contraception guidelines throughout the trial
• Female participants of reproductive potential who do not have a negative pregnancy blood or urine test at the screening stage
• People who have received another experimental treatment, chemotherapy, radiation therapy, or immunotherapy within 7 days before starting the trial
• People with a history of chronic hepatitis B or C, regardless of current viral activity levels
• People with a history of HIV
• People whose heart function is classified as Class III or IV on a standard heart failure scale, or whose heart pumping function (ejection fraction) is below 50% on a heart scan
• People who have had a heart attack or blood clot-related event within the past 6 months, or who have unstable or uncontrolled chest pain (angina), or a history of severe or uncontrolled abnormal heart rhythms
• People with psychiatric conditions or personal circumstances that would make it difficult to follow the trial's requirements

Important: Always verify eligibility with the trial site directly before applying.